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Status unknownNCT05254821Updated Nov 14, 2022

Cell-free Tumor DNA as Minimal Residual Disease in Hodgkin Lymphoma Patients

An observational study in Hodgkin Lymphoma, sponsored by Federico II University. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by Federico II University · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
18 Years and older
Sex
All
01

Study summary

Molecular analysis identifies residual disease by overcoming the sensitivity of imaging methods and therefore has the potential for integrating with therapy provided by FDG-PET alone. It is a well known fact that tumor DNA circulating in plasma (ctDNA) reflects the mutational profile of tumor cells and can be used to non-invasively detect specific mutations of Hodgkin's lymphoma without the need for microdissecting the histological sample.

Read the detailed description

A clinical need, not yet met for the Hodgkin lymphoma disease, brings about the early and accurate identification of chemo-refractory patients who require stepping up of treatment as also, patients with good prognosis receiving treatment de-escalation.Molecular methods identify residual disease by overcoming the sensitivity of imaging methods and therefore have the potential to integrate the response to therapy provided by FDG-PET alone.

ctDNA modification from the basal time point to the interim can be used as a predictor of response to the ABVD scheme and as a complement to the interim-PET in the possible variation of the therapeutic schedule.

Clinical data and peripheral blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA BCT tubes) will be collected during the clinico/laboratory visits that are planned as per clinical routine at the time of diagnosis, at each cycle of chemotherapy, at the time of interim PET/CT, at the time of end of treatment PET/CT and during follow up.

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Conditions studied

  • Hodgkin Lymphoma

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Keywords

  • ctDNA
  • Next generation sequencing
  • Hodgkin lymphoma
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In context

Hodgkin Disease

914 studies on the registry are indexed under Hodgkin Disease; 136 are open to participants now.

This study's planned enrollment of 130 is close to the median of 130 across 125 observational studies indexed under Hodgkin Disease.

Browse Hodgkin Disease studies →

Lead sponsor

Federico II University is the lead sponsor of 365 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Male or female adults 18 years or older with a documented diagnosis of hodgkin lymphoma according to WHO 2016 classification

Eligibility criteria

Inclusion Criteria:

  • Male or female adults 18 years or older
  • Documented diagnosis of Hodgkin lymphoma (both classic and nodular predominant lymphocytes subtype) according to 2016 WHO classification
  • Willing and able to comply with scheduled study procedures
  • Evidence of a signed informed consent
  • ECOG performance status 0-2 (or 3, if disease related)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Sensitivity of interim ctDNA genotyping

    Sensitivity of interim ctDNA genotyping in identifying chemorefractory patients or patients with good prognosis (patients who do not progress after 24 months)

    Time frame: 24 months

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05254821
Responsible party
Marco Picardi (Professor, Federico II University) — Principal investigator
First posted
Feb 24, 2022
Start date
Jan 10, 2022
Primary completion
Feb 3, 2024 (estimated)
Completion
Feb 3, 2026 (estimated)
Last update
Nov 14, 2022

Study contacts

Claudia Giordano, MD
Contact
claudiagiordano91@hotmail.com
0817464289

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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